Tom Crawford discusses UK product liability law and potential impacts on the healthcare sector in Global Relay Intelligence & Practice

Time for change?

The UK's product liability regime is under review, with some calling for dramatic change to make consumer litigation claims easier.  Healthcare and life sciences businesses, those that insure them and investors in this sector (increasingly, private equity (PE)) should pay close attention. After decades of relative stability, the legal framework governing product safety claims is poised for its most significant transformation for 40 years.

The Law Commission is evaluating how the Consumer Protection Act 1987 framework (a regime originally designed for an analogue era of tangible, physical products) should evolve to address the rapid and ongoing advances in technology that have fundamentally reshaped the healthcare sector. For medical device manufacturers, pharmaceutical companies, and digital health providers, this could substantially expand exposure in ways that demand immediate attention, contingency planning and the need for strategic advice.

What's at stake?

Healthcare product liability is already on the rise, driven by growing consumer awareness, increasingly sophisticated and at times opportunistic claimant lawyer strategies, and a litigation funding market that has made high-value group actions more accessible than ever before. Recent high-profile group claims illustrate the scale of the challenge. For example, the metal-on-metal hips litigation saw hundreds of claimants pursue manufacturers over allegedly defective hip replacement devices and demonstrated that even well-established manufacturers with robust quality assurance processes can face existential liability risks.

Current UK law imposes strict liability on manufacturers for injuries caused by defective products. This means claimants need not prove negligence, only that the product was defective and caused their injury. The existing framework covers design flaws that render an entire product line unsafe, manufacturing errors affecting individual units, and inadequate warnings or instructions that fail to alert users to foreseeable risks. The Law Commission's review could make defending these claims considerably harder, shifting the balance of litigation risk in favour of claimants and creating new procedural hurdles for defendants.

The shadow cast by Europe

Despite Brexit, the UK may follow elements of the new EU regime (Product Liability Directive 2024/2853), which will be fully implemented across EU Member States by December 2026.

The new Directive significantly redefines the concept of "products" to include software, AI systems, and digital services. For the healthcare sector, this expanded definition could capture a wide range of modern medical technologies: diagnostic algorithms that analyse patient data, consumer-facing health apps that monitor vital signs, and even software updates that modify device functionality after deployment, including products that use machine learning to automatically learn and acquire new features after being placed on the market.

Critically, the new EU regime is substantially more claimant-friendly than existing UK law, extending the limitation period to up to 25 years for latent personal injuries and introducing legal presumptions that operate against defendant companies. Where claimants can demonstrate certain threshold facts, the burden shifts to manufacturers to prove their products were not defective. This would be a significant departure from traditional common law principles in the UK. It also generates for manufacturers the spectre of further inconsistency when it comes to the supply of essentially the same products to essentially the same consumers in the UK and its closest neighbours.  That inconsistency would have been exacerbated by differing approaches within the UK; however, that spectre should be avoided as, although this review is being undertaken by the Law Commission of England and Wales, it has committed to consulting with stakeholders in Scotland and Northern Ireland to record any relevant differences between the laws of the components parts of the UK. The Law Commission will also seek to liaise with the relevant devolved administrations to obtain relevant input.

The range of potentially liable parties also expands beyond conventional manufacturers to include those who modify products outside the control of the original manufacturer, authorised representatives, and even, in certain circumstances, online platforms that facilitate product distribution. For healthcare businesses with complex supply chains involving multiple technology partners (and those PE houses that have invested heavily in this sector, especially following the Downing Street's post-COVID push to make the UK the number one life sciences hub in Europe by 2030), this expanded liability net may create new risks that existing contractual and insurance arrangements do not adequately address.

If the UK follows the EU, healthcare companies may face a materially different litigation landscape here. This could include expanded pre-action disclosure obligations requiring defendants to provide technical documentation, testing data, and safety records at an earlier stage of proceedings than is currently required or face a presumption that their product is defective. This obligation may extend to documents that have to be created "ex novo" by defendants compiling and classifying the available evidence for claimants. For healthcare defendants accustomed to defending complex scientific and technical disputes, these broader disclosure requirements will likely increase litigation costs and early-stage exposure significantly.

This debate highlights the multi-faceted nature of consumer protection.  Advocates for radical change will say that reform is required to allow easier access to litigation remedies to perceived failings and regulatory inertia.  But consumer protection in a broader sense needs not to stifle investment and development of new technologies to innovate and improve healthcare products that may be genuinely life changing for millions of Britons.

Act Now?

The Law Commission's final report is still months away, but this should not encourage complacency. By the time a final report emerges, the opportunity to shape future reforms will have largely passed. The review's stated objectives include "providing greater legal certainty in the digital age" and ensuring an appropriate balance between consumer protection and "support for business." These dual objectives suggest that the Law Commission is open to industry perspectives on how reform should be structured, but only if those perspectives are effectively communicated soon.

There is a narrow but critical window for stakeholder voices to be heard. Without robust industry input presenting the practical realities of healthcare product development and safety monitoring, reforms may (over) tilt toward claimant-friendly rules that fail to account for the genuine complexities of bringing innovative medical technologies to market. Those that wish to share their views with the Law Commission can do so by email at [email protected].

The Bottom Line

Change is coming: the only question is its shape, and whether some of those most impacted will have played a meaningful role in determining it. Companies in the healthcare sector (or those that insure or invest in those businesses) should take proactive steps now.

First, they should consider engaging directly with the Law Commission process to ensure that reform proposals reflect the realities of healthcare innovation. Second, they should conduct a thorough review of existing supply chain agreements to identify indemnification gaps that could leave them exposed under an expanded liability framework. Third, and perhaps most importantly, they should begin preparing for a fundamentally different litigation environment, one where proving a product is not defective may become considerably harder than proving it is. Those that act decisively now, assisted by specialist legal advice, will be best positioned to navigate and overcome the challenges ahead.